BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1822930 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-04046
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-03945, 2134265-2010-03946, 2134265-2010-03947. SAME PATIENT AS MFR REPORT #: 2134265-2010-04047. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE, THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION. USING THE RIGHT RADIAL APPROACH, THE INDEX PROCEDURE ADVANCED A 3.0X16MM TAXUS LIBERTE STENT TO THE TARGET LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT THE STENT DID NOT CROSS THE LESION. THE STENT WAS REMOVED AND THE LESION WAS PRE-DILATED WITH A 3.0X15MM APEX BALLOON INFLATED TWICE TO 10 ATM'S FOR 5 AND 8 SECONDS RESULTING IN A GRADE A VESSEL DISSECTION. THE SAME 3.0X16MM TAXUS LIBERTE STENT WAS AGAIN ADVANCED TO THE DISTAL LAD AND DEPLOYED AT 14 ATM'S FOR 12 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. NEXT A 3.0X20MM TAXUS LIBERTE WAS ADVANCED TO THE MID LAD AND DEPLOYED AT 16 ATM'S FOR 10 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. BAILOUT TREATMENT FOR THE VESSEL DISSECTION PLACED AN OVERLAPPING 3.0X12MM TAXUS LIBERTE STENT PROXIMAL TO THE PREVIOUSLY PLACED 3.0X16 TAXUS LIBERTE PLACED IN THE DISTAL LAD, DEPLOYING THE STENT AT 16 ATM'S FOR 10 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED. SIX DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN AND ELEVATED ST SEGMENTS ON EKG. ANGIOGRAPHY REVEALED A NEW 95% STENOSED LESION JUST PROXIMAL TO THE STENTS PLACED DAYS BEFORE. TREATMENT CONSISTED OF PRE-DILATION WITH A 2.0X12MM APEX BALLOON AND THE PLACEMENT OF A 2.25X12MM TAXUS ATOM STENT DEPLOYED AT 14 ATM'S FOR 25 SECONDS. A FOLLOW UP ANGIOGRAM DEMONSTRATED PLAQUE SHIFT DISTALLY AND A OVERLAPPING 2.25X8MM TAXUS ATOM WAS DEPLOYED AT 14 ATM'S FOR 25 SECONDS. A FOLLOW UP ANGIOGRAM AT THIS POINT DEMONSTRATED A WIDELY PATENT VESSEL RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616300 12870684

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 3.0X20MM TAXUS LIBERTE| 3.0X12MM TAXUS LIBERTE